Condition category
Circulatory System
Date applied
26/04/2011
Date assigned
20/05/2011
Last edited
30/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Alun Davies

ORCID ID

Contact details

Academic Section of Vascular Surgery
4E
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P34317

Study information

Scientific title

Ambulatory Varicosity avUlsion Later or Synchronised (AVULS): a randomised trial

Acronym

AVULS

Study hypothesis

Radiofrequency ablation with concomitant phlebectomy will result in an improvement in quality of life 6 months, reduce the need for further procedures and will be more cost effective than sequential phlebectomy or foam sclerotherapy

Ethics approval

1. Brighton and Sussex Research Ethics Committee approved on 21/03/2011, REC Reference Number 11/H1107/3
2. Joint Research Office, Imperial College London and Imperial College Healthcare NHS Trust approved on 30/03/2011, Reference Number JROHH0210

Study design

Randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Varicose Veins

Intervention

1. Simultaneous or delayed avulsion of superficial varicosities in the context of endovenous radiofrequency ablation of refluxing truncal veins
2. Avulsions will be delayed by 6 weeks post initial procedure if in delayed group
3. Followed up after 1 year

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Disease specific quality of life at 6 months using the Aberdeen Varicose Vein Questionnaire (AVVQ)

Secondary outcome measures

1. The need for further procedures over the 6 month period
2. Generic quality of life assessed using the EQ-5D
3. Cost effectiveness of the treatment strategies
4. Anatomical success assessed with colour duplex at 6 months
5. Level of depression assessed using Center for Epidemiologic Studies Depression Scale (CES-D)
6. Return to work and normal activities
7. Clinical disease severity assessed using the Venous Clinical Severity Score (VCSS)

Overall trial start date

01/04/2011

Overall trial end date

31/03/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Consecutive patients who present to the department of vascular surgery at Charing Cross Hospital, who are willing to participate in the study
2. They must have clinical venous disease affecting either the long saphenous or short saphenous veins
3. They must be over the age of 18 and able to give consent for the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

Participant exclusion criteria

1. Patients under the age of 18 years
2. Those that are unable to consent
3. Patients with deep venous disease
4. Those unfit for intervention

Recruitment start date

01/04/2011

Recruitment end date

31/03/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Charing Cross Hospital
London
W6 8RF
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

AHSC Joint Research Office
Imperial College London and
Imperial College Healthcare NHS Trust
G02 Sir Alexander Fleming Building
South Kensington Campus
London
SW7 2AZ
United Kingdom

Sponsor type

University/education

Website

http://www.imperial.ac.uk/clinicalresearchgovernanceoffice

Funders

Funder type

Charity

Funder name

Graeme-Dixon Charitable Trust (UK) (ref: P34317)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/24950277

Publication citations

Additional files

Editorial Notes